Undergraduate Certificate in Quality Assurance in Pharma Labs
-- ViewingNowThe Undergraduate Certificate in Quality Assurance in Pharma Labs is a comprehensive course designed to equip learners with essential skills for success in the pharmaceutical industry. This program emphasizes the importance of quality assurance in pharmaceutical labs, covering topics such as regulatory compliance, laboratory techniques, and data analysis.
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โข Fundamentals of Quality Assurance in Pharma Labs: An introduction to the core principles and practices of quality assurance in pharmaceutical laboratories, including regulatory requirements and industry standards.
โข Good Laboratory Practices (GLP): An exploration of GLP regulations, compliance, and their role in ensuring the quality and integrity of laboratory data in pharmaceutical settings.
โข Quality Control and Quality Assurance Tools: An overview of essential tools and techniques for quality control and quality assurance, such as statistical process control, failure mode and effects analysis (FMEA), and quality management systems.
โข Pharmaceutical Validation: A deep dive into the validation process for pharmaceutical products, equipment, and systems, covering topics like installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ).
โข Regulatory Compliance and Inspection Preparedness: A guide to understanding and navigating regulatory requirements from organizations like the FDA, EMA, and ICH, as well as preparing for and managing inspections.
โข Documentation and Record Keeping: Best practices for creating, maintaining, and managing documentation and records in pharmaceutical laboratories, emphasizing accuracy, completeness, and traceability.
โข Change Management and Risk Assessment: Strategies for managing changes in the pharmaceutical laboratory environment, including risk assessment, impact analysis, and implementation planning.
โข Quality Assurance in Analytical Methods: Techniques for ensuring the quality and reliability of analytical methods used in pharmaceutical laboratories, including method validation and verification.
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